Manufacturing Engineer I

Nissha Medical Technologies

Sandpoint, Idaho
30+ days ago

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Skills

Analysis Skillsunmatched
Biotech and Pharmaceuticalunmatched
CAD (Computer-Aided Design) Softwareunmatched
Change Controlunmatched
Code of Federal Regulationsunmatched
Communication Skillsunmatched
Continuous Improvementunmatched
Cost Controlunmatched
Cross-Functionalunmatched
Detail Orientedunmatched
Document Controlunmatched
Documentationunmatched
ERP (Enterprise Resource Planning)unmatched
Engineering Change Orderunmatched
Equipment Validationunmatched
Establish Prioritiesunmatched
FDA (Food and Drug Administration)unmatched
Failure Mode and Effects Analysis (FMEA)unmatched
ISO (International Organization for Standardization)unmatched
Industrial Engineeringunmatched
Interpersonal Skillsunmatched
Lean Manufacturingunmatched
Maintain Complianceunmatched
Manufacturingunmatched
Manufacturing Engineeringunmatched
Manufacturing Equipmentunmatched
Manufacturing/Industrial Processesunmatched
Medical Equipmentunmatched
Minitabunmatched
Multitaskingunmatched
Office Equipmentunmatched
Operational Supportunmatched
Organizational Skillsunmatched
Physical Demandsunmatched
Problem Solving Skillsunmatched
Process Developmentunmatched
Process Improvementunmatched
Process Validationunmatched
Product Documentationunmatched
Production Supportunmatched
Project/Program Managementunmatched
Quality Managementunmatched
Regulationsunmatched
Regulatory Complianceunmatched
Reporting Skillsunmatched
Risk Managementunmatched
Safety/Work Safetyunmatched
SolidWorksunmatched
Team Playerunmatched
Technical Supportunmatched
Technical Writingunmatched
Time Managementunmatched
Tool and Die Manufacturingunmatched
Validation Planunmatched
Value Stream Mappingunmatched
Workflow Analysisunmatched
eCosunmatched

Description

JOB DESCRIPTION

Nissha Medical Technologies is looking for a Manufacturing Engineer I to join our Sandpoint, ID. Team!

The Manufacturing Engineer I supports the production and quality teams by developing, maintaining, and improving manufacturing processes and documentation within a regulated medical device manufacturing environment. This role is responsible for authoring and executing equipment and process validations (IQ/OQ/PQ), developing and supporting risk management tools (FMEAs), and participating in cross-functional projects that improve quality, efficiency, and safety. While recent graduates will be considered, preference will be given to candidates with previous experience in the medical device or other FDA-regulated industries.

ESSENTIAL DUTIES AND RESPONSIBILITIES (other duties may be assigned)

Documentation & Change Control

Create and maintain technical documentation including engineering change orders (ECOs), drawings, work instructions, and procedures in accordance with internal document control processes
Support change control efforts related to products, processes, and customer requirements

Validation & Risk Management

Develop and execute equipment and process validation protocols following IQ/OQ/PQ methodology
Analyze and interpret validation results; prepare comprehensive reports that meet internal and regulatory standards
Support and co-develop Process and Design FMEAs in coordination with cross-functional teams

Process Development & Improvement

Assist in the design and implementation of manufacturing equipment, tooling, and fixtures
Conduct time studies and workflow analyses to support production efficiency
Apply Lean Manufacturing principles (e.g., 5S, Kaizen, Value Stream Mapping) to improve quality, reduce cost, and increase throughput
Collaborate with production teams to identify, evaluate, and implement process improvements

Cross-Functional Collaboration

Participate in cross-functional meetings with Engineering, Quality, and Production to resolve technical issues and support operational goals
Promote a culture of safety and continuous improvement within the engineering function
Ensure compliance with applicable regulations, including ISO 13485 and FDA 21 CFR Part 820

MINIMUM QUALIFICATIONS

Qualifications & Experience

Prior experience in an FDA-regulated environment strongly preferred (medical device, pharmaceutical, diagnostics, etc.)
Recent graduates with relevant internship, co-op, or project-based experience in a regulated environment are encouraged to apply

Education

Bachelor's degree in Mechanical, Manufacturing, Industrial Engineering, or a related technical field
Equivalent combination of education and relevant experience in manufacturing engineering may be considered

Knowledge, Skills & Abilities

Proficiency with SolidWorks or similar 3D CAD software required
Familiarity with validation practices including IQ/OQ/PQ and supporting documentation
Understanding of FMEA methodology and risk management principles
Experience with Lean Manufacturing tools (5S, Kaizen, VSM) preferred
Familiarity with statistical tools (e.g., Minitab, Excel) and ERP/MRP systems is a plus
Strong interpersonal and teamwork skills with ability to work across departments
Excellent communication skills with the ability to clearly document and explain complex technical issues
Detail-oriented with strong organizational and time management skills
Ability to prioritize and manage multiple projects simultaneously
Self-motivated and accountable; able to follow direction and work independently when needed

Physical Requirements
This position requires the physical ability to:

Frequently remain in a stationary position for long periods of time
Occasionally move between buildings and offices
Frequently operate a computer and other office equipment
Constantly and successfully communicate with employees, managers, and members of the public, in person and on the phone, regarding sensitive matters, discern and convey emotion, and understand and exchange accurate information
Occasionally lift and move up to 45 pounds
Constantly recognize detail, inspect documents and product, observe behavior, and recognize potential violations or hazards
Occasionally ascend/descend stairs to access work areas

Reasonable accommodations may be made to enable individuals with disabilities to perform th

Numbers & Facts

Location

Sandpoint, Idaho

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